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Sonablate HIFU International Registry for PC & BPH Patients

SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system."
  • "While high-intensity focused ultrasound (HIFU) has emerged as a recognized, minimally invasive alternative, existing clinical evidence often lacks prospective, long-term follow-up and standardized, validated outcome assessments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks the long-term safety and results of Sonablate HIFU, a treatment that uses focused ultrasound to destroy prostate tissue. It is for adult men treated for prostate cancer that has not spread beyond the prostate, an enlarged prostate not caused by cancer (BPH), or both. It collects medical records over 10 to 20 years and does not assign experimental treatments.

The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period. The study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adult men diagnosed with prostate cancer that has not spread beyond the prostate or BPH.
  • Have received Sonablate HIFU as part of regular medical care. Records must wait at least 180 days after treatment before being sent to the study's central center.

Who can't join

  • Prostate size or the location of the area needing treatment prevents effective HIFU targeting. Size limits are over 100 cubic centimeters for prostate cancer or over 80 cubic centimeters for BPH.
  • Prostate cancer has spread to other parts of the body.
  • Have had surgery to remove the whole prostate.
  • Have calcium deposits larger than 10 millimeters in the prostate that block the ultrasound view.
  • Have had surgery on the wall of the rectum, or cannot have an ultrasound using a probe placed in the rectum.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male with diagnosed localized prostate cancer or BPH (benign prostatic hyperplasia) * Having undergone Sonablate HIFU ablation as part of standard clinical care, with all central data transmission subject to a mandatory 180-day post-procedure delay. Exclusion Criteria: * Prostate size or lesion location precluding effective HIFU target acquisition (prostate volume \>100 CC for prostate cancer or \>80 CC for BPH) * Confirmed metastatic prostate cancer * Prior radical prostatectomy * Prostates with large calcifications (\>10mm causing shadowing) * Prior rectal wall surgery or inability to undergo transrectal ultrasound

Study sites (1)

IN